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Results of the National Paediatric Bilateral Cochlear Implant Surgical Audit Mr Stephen Broomfield ENT Locum Consultant University Hospitals Bristol Southampton,

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Presentation on theme: "Results of the National Paediatric Bilateral Cochlear Implant Surgical Audit Mr Stephen Broomfield ENT Locum Consultant University Hospitals Bristol Southampton,"— Presentation transcript:

1 Results of the National Paediatric Bilateral Cochlear Implant Surgical Audit Mr Stephen Broomfield ENT Locum Consultant University Hospitals Bristol Southampton, April 2013

2 Acknowledgements Co-ordinating team: – Professor G O’Donoghue – John Murphy, Steve Emmett, Dominik Wild Nottingham University Hospitals NHS Trust Working on behalf of: – The UK National Paediatric Cochlear Implant Surgical Audit Group

3 14 Contributing Centres BelfastMiddlesbrough BirminghamNottingham Bradford Oxford BristolRNTNE CambridgeSouthampton GOSHSt George’s Manchester St Thomas’s

4 Acknowledgement Funding for surgical audit: – Supported by a grant from the Healthcare Quality Improvement Partnership (HQIP)

5 Aims To establish a large dataset of national paediatric cochlear implant procedures To generate evidence for establishing future best surgical practice Governance issues in early days of bilateral CI Data for BCIG review of service Data for NICE’s requirement to audit service

6 Aims To address the real concern about surgery/ anaesthesia of parents considering CI for their child Although risk of complications low following CI, potential might be increased with bilateral simultaneous CI e.g. blood loss, vestibular impairment

7 Methods Prospective multi-centre audit All CIs in children (birth to 18 yrs) included Surgeon completed voluntary questionnaire Collection Jan 2010 to Dec 2011 Data collected including: – Demographics – Aetiology – Co-morbidity – Electrophysiology/ imaging – Complications – Length of stay

8 Results - Demographics 961 CI recipients (1397 implants) – 436 bilateral simultaneous – 394 bilateral sequential – 131 unilateral Male:Female 474:462 (data missing n=25)

9 Results – Change in Surgery 8 cases (1.8%) of planned bilateral CI became unilateral: – Mucosal bleeding (n=3) – Cochlear obliteration (n=2) – Anaesthetic/medical concerns intra-op (n=2) – Anatomical difficulties (n=1)

10 Results - Age Age at Implantation (n=916) Years:Months – Mean age 6:1 (median 4:9, range 4m to 18y) – For congenitally deaf having bilateral CI (n=345): Mean age 3:1 (median 2:2, range 4m to 17:8) – For sequential CI (n= 383): Mean age 8:8 (median 8:2, range 7y to 18y)

11 Results - Aetiology Congenital n=799 (83%) – Majority unknown aetiologyn=639 (80%) – Connexin 26 n=41 (4.2%) – Ushern=14 (1.8%) – Waardenburgn=12 (1.5%) – Pendred n=10 (1.3%) Acquired n=141 (14.7%) – Meningitis n=55 (39.0%) – CMV n=35 (24.8%) Not specified n=21 (2.2%)

12 Results – Pre-op Imaging Recorded in 925 cases (96.3%) Both MRI and CT 511 (55.2%) MRI alone280 (30.2%) CT alone 134 (14.5%)

13 Results - Duration of Surgery n=631 (66%) Min MaxMeanMedian Bilateraln=28401:4008:4504:3204:15 Sequentialn=26201:0007:2502:2502:15 Unilateraln=8501:2509:4502:4402:30 Times in hours:minutes. Entering anaesthetic room to leaving theatre

14 Results - Duration of Surgery Data for Bilateral Simultaneous CI (n=284)

15 Results - Duration of Surgery Data for Bilateral Simultaneous CI (n=284)

16 Results - Duration of Surgery Duration of surgery for cases of bilateral simultaneous CI: – With trainee (n= 142)4:36 – No trainee (n=136)4:26 Extent of involvement/ complexity of cases not recorded

17 Results – Intra-operative Tests Documented in 910 cases (95%) – Telemetry to measure electrically evoked cortical action potential (ECAP) from auditory nerve in 626 (69%) – CI integrity test without full ECAP in 55 (6%) – Stapedial reflexes in 129 (14%)

18 Results – Post-op Imaging Documented in 854 (89%) cases: – Post op X-rayn=603 (71%) – Intra-op X-rayn=111 (13%) – Both intra- and post-opn=75 (9%) – No imagingn=65 (8%)

19 Results – Length of Stay n=795. Maximum length of stay was 9 days

20 Complications Major Complication An adverse event occurring during or after surgery (short term) that necessitated a further major surgical intervention, admission to ITU, exposure to invasive intervention or a permanent disability such as persistent facial weakness Minor Complication An adverse event managed (short term) by medical measures or by a minor surgical procedure (e.g. aspiration of a haematoma) Bhatia K, et al. Otol Neurotol 2004;25:730-739. Hansen S, et al. Acta Oto-laryngologcia 2010;130:540-549.

21 Complications Immediate – intra-operative or first week following surgery Delayed – occurring after one week, within the period of the audit Immediate and delayed major complications recorded Only immediate minor complications recorded

22 Immediate Major Complications CSF leak requiring lumbar drain2 (0.2%) Bleeding requiring transfusion1 (0.1%) Return to theatre to reposition1 (0.1%) No permanent facial palsy, no deaths

23 Delayed Major Complications Device failure6 (0.6%) Wound infection with explantation2 (0.2%) Meningitis 1 (0.1%) Wound infection drained in theatre1 (0.1%) Theatre for air collection over implant1 (0.1%) Note range of follow up 0 to 24m, mean 12.5m Overall major complication rate 1.6% (0.9% if device failures excluded)

24 Immediate Minor Complications Intra-op – CSF Leak4 (0.4%) – Tip rollover – device changed2 (0.2%) – Device not working – changed1 (0.1%) – Device repositioned1 (0.1%) Post-op – Imbalance – prolonged stay12 (1.3%) – Swelling – conservative mx11 (1.1%) – Bleeding/ haematoma - cons mx10 (1.0%) – Wound infection – abx7 (0.7%) – Tip rollover – no revision4 (0.4%) – Facial weakness – partial2 (0.2%)

25 Immediate Minor Complications 62 reported overall (6.5%) 12 cases of imbalance – 4 bilateral simultaneous, 5 sequential, 3 unilateral – Most (n=10) required one additional night – Maximum (n=2) required 3 nights 2 cases of partial (House Brackmann grade 3) facial weakness – Both resolved

26 Results - Complications Patients presenting with complications spread evenly across centres No differences detectable between bilateral simultaneous, sequential, unilateral

27 AuthorLocationN=Mean Age Mean F-up Wound explant % Facial paresis % Meningitis % CSF Leak % Device Failure % Current Study 2013 UK9616y1y0.2 Ding 2009 China1237*4y 8mNS0.50.300 Kim 2008 Korea572NS* (<14 y) 3y 6m*0.30.20NS1.7* Loundon 2010 France4344y 7m5y 6m2. Qiu 2011 China416* 6y2y 8m0.50.2NS0.5NS Trotter 2009 Australia402NS 0.7NS 4.4 Venail 2008 France3225y 7m6y 9m1.60.3NS 4.9 Bhatia 2004 UK3005y 1m4y0.30.700NS Ciorba 2012 Italy2984y 8m3y 10m*NS*00 Black 2007 UK2215y 2mNS2.30.500NS Kandogan 2005 Turkey205NS 00.400NS Hansen 2010 Denmark1872y 8m3y00.50NS Lescanne 2011 France1403y 7mNS1.40.70NS1.4 McJunkin 2010 USA136NS (<18y) > 3y0.70 0 Arnoldner 2005 Austria1285yNS00.80014

28 Conclusion Collaboration across the UK has allowed for one of the largest reported series to date All UK centres employ a similar approach: – Experienced teams – Modern surgical practices – Centres with access to paediatric, anaesthetic and ICU support (RCS Guidelines) – Adherence to immunisation protocols – Intra-operative precautions – High vigilance for complications

29 Conclusion – Areas for Improvement Longer follow up International consensus on reporting of complications Improved reporting of all audit data points

30 Conclusion Overall major complication rate 1.6% (0.9% excluding device failures) Comparable to other large series No permanent facial palsies, no deaths No evidence for increased complications following bilateral simultaneous compared to sequential or unilateral CI

31 Conclusion This study provides evidence that bilateral paediatric cochlear implantation, whether simultaneous or sequential, is a safe procedure in cochlear implant centres in the UK, thus endorsing its role as a major therapeutic intervention in childhood deafness.

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